Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen Innovation Act, 892-893 [2015-00002]

Download as PDF 892 Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Notices Board of Governors of the Federal Reserve System, January 2, 2015. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2015–00032 Filed 1–6–15; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2005–N–0453, FDA– 2003–N–0196, and FDA–2006–O–0314] Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen Innovation Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA or Agency) is announcing the availability of letters containing FDA’s initial determinations and feedback on safety and effectiveness data submitted to demonstrate that certain active ingredients are generally recognized as safe and effective (GRASE) and not misbranded for use in over-the-counter (OTC) sunscreen drug products (sunscreen feedback letters). We are taking this action under the Sunscreen Innovation Act (SIA). DATES: Submit either electronic or written comments by February 23, 2015. Sponsors may submit written requests for a meeting with FDA to discuss these proposed sunscreen orders by February 6, 2015. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should clearly identify the SUMMARY: specific active ingredient(s) and docket number(s) to which the comments apply. FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Division of Nonprescription Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5491, Silver Spring, MD 20993–0002, 240– 402–4246. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of six sunscreen feedback letters on its Web site that contain the Agency’s tentative determinations and feedback on safety and effectiveness data submitted to demonstrate that certain active ingredients are GRASE and not misbranded for use in OTC sunscreen drug products. We are taking this action under the SIA (Pub. L. 113–195), enacted November 26, 2014. Before the SIA was enacted, these sunscreen feedback letters were issued to persons seeking OTC monograph status for nonprescription sunscreen active ingredients using the Time and Extent Application (TEA) process under FDA regulations in 21 CFR 330.14, and were also previously made available to the public in the docket. The SIA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to, among other things, provide an alternative process for FDA to review the safety and effectiveness of nonprescription sunscreen active ingredients. The SIA establishes new procedures for establishing the conditions under which sunscreens containing active ingredients that have been reviewed through the SIA process and found in a final sunscreen order to be GRASE and not misbranded may be marketed in the United States. Section 586C(b)(3) of the FD&C Act, as added by the SIA, provides that sunscreen feedback letters issued before the SIA was enacted are deemed to be proposed sunscreen orders. Proposed sunscreen orders contain FDA’s tentative determination that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients: (A) Is GRASE and not misbranded if marketed in accordance with such order; (B) is not GRASE and is misbranded; or (C) is not GRASE and is misbranded because the data are insufficient to classify the active ingredient or combination of ingredients as GRASE and not misbranded, and additional data are necessary to allow FDA to determine otherwise. All of the proposed sunscreen orders addressed in this notice have been tentatively classified under category (C), as described in the previous sentence. Accordingly, additional data will be needed to support a determination that any or all of the active ingredients they address are GRASE and not misbranded. II. Sunscreen Feedback Letters Deemed To Be SIA Proposed Orders The six feedback letters that are deemed to be proposed orders under the SIA are identified in Table 1. They can be viewed electronically on FDA’s Web site at https://www.fda.gov/Drugs/ ResourcesForYou/Consumers/ BuyingUsingMedicineSafely/ UnderstandingOver-theCounterMedicines/ucm239463.htm, under the heading ‘‘FDA Regulatory Action on Sunscreen.’’ Related documents, including safety and efficacy data submissions, can be accessed in the corresponding dockets, identified in Table 1, at https:// www.regulations.gov. The letters and associated information may also be viewed by visiting FDA’s Division of Dockets Management (see ADDRESSES). TABLE 1—OTC SUNSCREEN FEEDBACK LETTERS DEEMED TO BE SIA PROPOSED ORDERS Sponsor Bemotrizinol ............................................................ Ciba Specialty Chemicals Corp ............................. 11/13/2014 Bisoctrizole .............................................................. Ciba Specialty Chemicals Corp ............................. 9/3/2014 Drometrizole Trisiloxane ......................................... rljohnson on DSK3VPTVN1PROD with NOTICES Active ingredient L’Oreal USA Products, Inc. .................................... 8/29/2014 Octyl Triazone ......................................................... BASF AG ................................................................ 6/23/2014 Amiloxate ................................................................ Symrise, Inc. .......................................................... Ego Pharmaceuticals Pty. Ltd. ............................... 3V Inc. .................................................................... 2/25/2014 Diethylhexyl Butamido Triazone ............................. 1 Each Date issued 2/21/2014 letter was previously posted in the docket shown in Table 1 on the date that it was issued. VerDate Sep<11>2014 15:01 Jan 06, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1 Docket No. 1 FDA–2005–N– 0453 FDA–2005–N– 0453 FDA–2003–N– 0196 FDA–2003–N– 0196 FDA–2003–N– 0196 FDA–2006–O– 0314 Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Notices Sponsors may submit a written request for a meeting with FDA to discuss any of these proposed sunscreen orders (see DATES). Submit meeting requests electronically to www.regulations.gov or in writing to the Division of Dockets Management (see ADDRESSES), identified with the active ingredient name(s), the corresponding docket number(s) shown in Table 1, and the heading ‘‘Sponsor Meeting Request.’’ To facilitate your request, please also send a copy to Kristen Hardin (see FOR FURTHER INFORMATION CONTACT). III. Comments Interested persons may submit either electronic comments about the proposed orders discussed in this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the appropriate docket number(s) and active ingredient name(s) shown in Table 1 for the proposed order(s) that the comments address. Comments on this notice may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the appropriate docket(s) at https://www.regulations.gov. Dated: December 31, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–00002 Filed 1–6–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [CIS No. 2550–14; DHS Docket No. USCIS– 2007–0028] RIN 1615–ZB36 Extension of the Designation of El Salvador for Temporary Protected Status U.S. Citizenship and Immigration Services, Department of Homeland Security. ACTION: Notice. rljohnson on DSK3VPTVN1PROD with NOTICES AGENCY: Through this Notice, the Department of Homeland Security (DHS) announces that the Secretary of Homeland Security (Secretary) is extending the designation of El Salvador for Temporary Protected Status (TPS) for 18 months from March 10, 2015, through September 9, 2016. SUMMARY: VerDate Sep<11>2014 15:01 Jan 06, 2015 Jkt 235001 The extension allows currently eligible TPS beneficiaries to retain TPS through September 9, 2016, so long as they otherwise continue to meet the eligibility requirements for TPS. The Secretary has determined that an extension is warranted because the conditions in El Salvador that prompted the TPS designation continue to be met. There continues to be a substantial, but temporary, disruption of living conditions in El Salvador resulting from a series of earthquakes in 2001, and El Salvador remains unable, temporarily, to handle adequately the return of its nationals. Through this Notice, DHS also sets forth procedures necessary for nationals of El Salvador (or aliens having no nationality who last habitually resided in El Salvador) to re-register for TPS and to apply for renewal of their Employment Authorization Documents (EADs) with U.S. Citizenship and Immigration Services (USCIS). Reregistration is limited to persons who have previously registered for TPS under the designation of El Salvador and whose applications have been granted. Certain nationals of El Salvador (or aliens having no nationality who last habitually resided in El Salvador) who have not previously applied for TPS may be eligible to apply under the late initial registration provisions, if they meet: (1) At least one of the late initial filing criteria; and, (2) all TPS eligibility criteria (including continuous residence in the United States since February 13, 2001, and continuous physical presence in the United States since March 9, 2001). For individuals who have already been granted TPS under the El Salvador designation, the 60-day re-registration period runs from January 7, 2015 through March 9, 2015. USCIS will issue new EADs with a September 9, 2016 expiration date to eligible El Salvador TPS beneficiaries who timely re-register and apply for EADs under this extension. Given the timeframes involved with processing TPS reregistration applications, DHS recognizes that not all re-registrants will receive new EADs before their current EADs expire on March 9, 2015. Accordingly, through this Notice, DHS automatically extends the validity of EADs issued under the TPS designation of El Salvador for 6 months, through September 9, 2015, and explains how TPS beneficiaries and their employers may determine which EADs are automatically extended and their impact on Employment Eligibility Verification (Form I–9) and the E-Verify processes. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 893 The 18-month extension of the TPS designation of El Salvador is effective March 10, 2015, and will remain in effect through September 9, 2016. The 60-day re-registration period runs from January 7, 2015 through March 9, 2015March 9, 2015. (Note: It is important for re-registrants to timely re-register during this 60-day reregistration period and not to wait until their EADs expire.) FOR FURTHER INFORMATION CONTACT: • For further information on TPS, including guidance on the application process and additional information on eligibility, please visit the USCIS TPS Web page at https://www.uscis.gov/tps. You can find specific information about this extension of El Salvador for TPS by selecting ‘‘TPS Designated Country: El Salvador’’ from the menu on the left of the TPS Web page. • You can also contact the TPS Operations Program Manager at the Family and Status Branch, Service Center Operations Directorate, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue NW., Washington, DC 20529–2060; or by phone at (202) 272–1533 (this is not a toll-free number). Note: The phone number provided here is solely for questions regarding this TPS Notice. It is not for individual case status inquires. • Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at https:// www.uscis.gov, or call the USCIS National Customer Service Center at 800–375–5283 (TTY 800–767–1833). Service is available in English and Spanish. • Further information will also be available at local USCIS offices upon publication of this Notice. SUPPLEMENTARY INFORMATION: DATES: Table of Abbreviations BIA—Board of Immigration Appeals DHS—Department of Homeland Security DOS—Department of State EAD—Employment Authorization Document FNC—Final Nonconfirmation Government—U.S. Government IJ—Immigration Judge INA—Immigration and Nationality Act OSC—U.S. Department of Justice, Office of Special Counsel for Immigration-Related Unfair Employment Practices SAVE—USCIS Systematic Alien Verification for Entitlements Program Secretary—Secretary of Homeland Security TNC—Tentative Nonconfirmation TPS—Temporary Protected Status TTY—Text Telephone USCIS—U.S. Citizenship and Immigration Services E:\FR\FM\07JAN1.SGM 07JAN1

Agencies

[Federal Register Volume 80, Number 4 (Wednesday, January 7, 2015)]
[Notices]
[Pages 892-893]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2005-N-0453, FDA-2003-N-0196, and FDA-2006-O-0314]


Sunscreen Feedback Letters; Notice of Availability Under the 
Sunscreen Innovation Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of letters containing FDA's initial determinations and 
feedback on safety and effectiveness data submitted to demonstrate that 
certain active ingredients are generally recognized as safe and 
effective (GRASE) and not misbranded for use in over-the-counter (OTC) 
sunscreen drug products (sunscreen feedback letters). We are taking 
this action under the Sunscreen Innovation Act (SIA).

DATES: Submit either electronic or written comments by February 23, 
2015. Sponsors may submit written requests for a meeting with FDA to 
discuss these proposed sunscreen orders by February 6, 2015.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should clearly identify the specific 
active ingredient(s) and docket number(s) to which the comments apply.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Division of 
Nonprescription Drug Products, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 
5491, Silver Spring, MD 20993-0002, 240-402-4246.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of six sunscreen feedback 
letters on its Web site that contain the Agency's tentative 
determinations and feedback on safety and effectiveness data submitted 
to demonstrate that certain active ingredients are GRASE and not 
misbranded for use in OTC sunscreen drug products. We are taking this 
action under the SIA (Pub. L. 113-195), enacted November 26, 2014. 
Before the SIA was enacted, these sunscreen feedback letters were 
issued to persons seeking OTC monograph status for nonprescription 
sunscreen active ingredients using the Time and Extent Application 
(TEA) process under FDA regulations in 21 CFR 330.14, and were also 
previously made available to the public in the docket.
    The SIA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
to, among other things, provide an alternative process for FDA to 
review the safety and effectiveness of nonprescription sunscreen active 
ingredients. The SIA establishes new procedures for establishing the 
conditions under which sunscreens containing active ingredients that 
have been reviewed through the SIA process and found in a final 
sunscreen order to be GRASE and not misbranded may be marketed in the 
United States.
    Section 586C(b)(3) of the FD&C Act, as added by the SIA, provides 
that sunscreen feedback letters issued before the SIA was enacted are 
deemed to be proposed sunscreen orders. Proposed sunscreen orders 
contain FDA's tentative determination that a nonprescription sunscreen 
active ingredient or combination of nonprescription sunscreen active 
ingredients: (A) Is GRASE and not misbranded if marketed in accordance 
with such order; (B) is not GRASE and is misbranded; or (C) is not 
GRASE and is misbranded because the data are insufficient to classify 
the active ingredient or combination of ingredients as GRASE and not 
misbranded, and additional data are necessary to allow FDA to determine 
otherwise. All of the proposed sunscreen orders addressed in this 
notice have been tentatively classified under category (C), as 
described in the previous sentence. Accordingly, additional data will 
be needed to support a determination that any or all of the active 
ingredients they address are GRASE and not misbranded.

II. Sunscreen Feedback Letters Deemed To Be SIA Proposed Orders

    The six feedback letters that are deemed to be proposed orders 
under the SIA are identified in Table 1. They can be viewed 
electronically on FDA's Web site at https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm239463.htm, under the heading ``FDA Regulatory 
Action on Sunscreen.'' Related documents, including safety and efficacy 
data submissions, can be accessed in the corresponding dockets, 
identified in Table 1, at https://www.regulations.gov. The letters and 
associated information may also be viewed by visiting FDA's Division of 
Dockets Management (see ADDRESSES).

                    Table 1--OTC Sunscreen Feedback Letters Deemed To Be SIA Proposed Orders
----------------------------------------------------------------------------------------------------------------
             Active ingredient                          Sponsor                Date issued       Docket No. \1\
----------------------------------------------------------------------------------------------------------------
Bemotrizinol...............................  Ciba Specialty Chemicals Corp         11/13/2014    FDA-2005-N-0453
Bisoctrizole...............................  Ciba Specialty Chemicals Corp           9/3/2014    FDA-2005-N-0453
Drometrizole Trisiloxane...................  L'Oreal USA Products, Inc....          8/29/2014    FDA-2003-N-0196
Octyl Triazone.............................  BASF AG......................          6/23/2014    FDA-2003-N-0196
Amiloxate..................................  Symrise, Inc.................          2/25/2014    FDA-2003-N-0196
                                             Ego Pharmaceuticals Pty. Ltd.
Diethylhexyl Butamido Triazone.............  3V Inc.......................          2/21/2014    FDA-2006-O-0314
----------------------------------------------------------------------------------------------------------------
\1\ Each letter was previously posted in the docket shown in Table 1 on the date that it was issued.


[[Page 893]]

    Sponsors may submit a written request for a meeting with FDA to 
discuss any of these proposed sunscreen orders (see DATES). Submit 
meeting requests electronically to www.regulations.gov or in writing to 
the Division of Dockets Management (see ADDRESSES), identified with the 
active ingredient name(s), the corresponding docket number(s) shown in 
Table 1, and the heading ``Sponsor Meeting Request.'' To facilitate 
your request, please also send a copy to Kristen Hardin (see FOR 
FURTHER INFORMATION CONTACT).

III. Comments

    Interested persons may submit either electronic comments about the 
proposed orders discussed in this document to https://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the appropriate docket number(s) and 
active ingredient name(s) shown in Table 1 for the proposed order(s) 
that the comments address. Comments on this notice may be viewed in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the appropriate docket(s) at 
https://www.regulations.gov.

    Dated: December 31, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00002 Filed 1-6-15; 8:45 am]
BILLING CODE 4164-01-P

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